Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care

Recruiting Phase 3 Interventional Study
Glioblastoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
766 (estimated)
Sponsor
GT Medical Technologies, Inc. · Industry
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About This Trial
This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows: * A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B. * A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B). * A…
Trial Locations
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Eligibility Criteria
Major Criteria Includes the Following: Inclusion Criteria * Patients must be ≥18 years of age. * Have radiographic suspicion of newly diagnosed glioblastoma (GBM). o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL…
Contacts

Kimberly Johnson

(833)662-0044

kjohnson@gammatile.com

CONTACT